Game-Based Learning Intervention for Health Behaviors

(UTC Trial)

Enrolling by invitation at 2 trial locations

Overseen By Brittany Rosen, PhD, MeD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Unable to read and speak English

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 8 hours total

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an innovative game-based program called Using the Connect, designed to promote healthy behaviors and reduce teen pregnancies. The program will be implemented in Texas middle schools and community organizations to help young people make informed decisions about their sexual health. The trial will compare students participating in the program with those who do not receive this intervention. It suits middle school students in Texas who can read and speak English and are interested in engaging with a new learning tool. As an unphased trial, it offers students a unique opportunity to engage with a cutting-edge educational tool that could positively impact their health decisions.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What prior data suggests that this game-based intervention is safe for adolescents?

Research shows that using games for learning is generally safe and well-received in schools. Studies have found that games can effectively change behaviors and attitudes. For instance, a study on a mobile game designed to improve children's safety showed positive results without any serious side effects. This suggests that game-based programs like Using the Connect are likely safe for middle school students. While specific safety data for Using the Connect is unavailable, similar programs have demonstrated safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Game-Based Learning Intervention for Health Behaviors because it offers a unique approach to educating middle school-aged youth about healthy behaviors, particularly in sexual health. Unlike traditional health education methods that can be lecture-based and less engaging, this program uses interactive games to teach important skills like decision-making, communication, and accessing information. By facilitating a safe environment for youth to connect with adults in their community, the program not only aims to educate but also to empower young people to lead healthy lives. This method could revolutionize how health education is delivered by making it more engaging and effective for the digital generation.

What evidence suggests that the "Using the Connect" game-based intervention is effective for promoting healthy behaviors and preventing adolescent pregnancy?

Research has shown that "Using the Connect" (UTC), which participants in this trial may receive, is a promising tool for improving sexual health education among middle school students. Studies have found that game-based programs like UTC are practical and well-received by young people, promoting healthy behaviors through interactive learning. UTC focuses on making the learning process relatable and effective for students. Serious gaming has been recognized as an innovative and effective method for teaching sexual health, encouraging students to delay sexual activity. These findings suggest that UTC could effectively reduce adolescent pregnancies and promote healthy behaviors. ^{6 7 8 9 10}

Who Is on the Research Team?

Brittany Rosen, PhD, MEd

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

This trial is for middle school-aged youth in Texas who can read and complete surveys in English without help. They must be at one of the participating schools or community organizations. It's not open to those who cannot read and speak English.

Inclusion Criteria

Ability to complete Using the Connect in English

Ability to read and complete surveys in English without assistance

I am a middle school student at a participating site in Texas.

Exclusion Criteria

I cannot read or speak English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete validated surveys prior to participating in the treatment or control group

1 week

1 visit (in-person or virtual)

Treatment

Participants engage in the Using the Connect (UTC) game-based intervention, consisting of four games and a take-away activity

8 hours total

Multiple sessions (in-person)

Immediate Post-Assessment

Participants complete surveys immediately after participating in the treatment or control group

1 week

1 visit (in-person or virtual)

Follow-up

Participants are monitored for changes in intention to delay sexual intercourse at 3-month and 9-month follow-up surveys

9 months

2 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Using the Connect

Trial Overview

The study tests 'Using the Connect' (UTC), a game-based intervention aimed at increasing protective factors against adolescent pregnancy and STI rates by encouraging youths to delay sexual activity.

How Is the Trial Designed?

Group I: Using the Connect Experimental Treatment 1 Intervention

Using The Connect (UTC) is a game-based learning program designed for middle school-aged youth (ages 9-15 or grades 6-8) consisting of four games played in a facilitated environment, and one take-away activity. The goals of the program include:To be a vehicle that encourages community sharing of healthy teen behavior. To facilitate safe connections between youth and adults in their community. To empower youth to lead healthy sexual lives. The four games each focus on specific health content or skills including growth and development, accessing information, positive communication, and decision-making. Each of the four games is intended to be played for a total of 90 minutes, split up into sessions of 30 minutes per game. When combining all gameplay sessions, along with the instructions for the take-away activity and program wrap-up activity, organizations will dedicate approximately 8 hours to the program.

Group II: Business as Usual Active Control 1 Intervention

Participants will not receive the Using the Connect curriculum.

Using the Connect is already approved in United States for the following indications:

Approved in United States as Using the Connect for:

• Adolescent pregnancy prevention
• Sexually transmitted infection (STI) prevention

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Texas A&M University

Collaborator

Trials

156

Recruited

28,900+

Published Research Related to This Trial

The Food Game intervention successfully engaged high school students in Northern Italy through gamification, promoting peer-led activities and competition, although it did not significantly change adherence to the Mediterranean diet.

While there was no notable improvement in dietary adherence, students showed increased pro-environmental behaviors and positive attitudes towards healthy eating, suggesting the program's potential as a motivational strategy for promoting healthier lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Process Evaluation of Food Game: A Gamified School-Based Intervention to Promote Healthier and More Sustainable Dietary Choices. Aresi, G., Giampaolo, M., Chiavegatti, B., et al.[2023]

In a study of 22,056 acute care encounters for children aged 2 to 17, only 1.5% had reported safety events, highlighting the low rate of adverse event reporting in this setting.

The study found that obesity and African American race were negatively associated with safety event reporting, suggesting potential biases in voluntary event reporting systems that may overlook certain demographic groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Characteristics Associated With Voluntary Safety Event Reporting in the Acute Care Setting. Thurtle, DP., Daffron, SB., Halvorson, EE.[2020]

Digital game-based approaches, including serious games and gamification, can effectively promote health-related information and encourage behavior change, particularly among hard-to-reach audiences.

These playful applications leverage game design elements to enhance motivation and engagement, making them valuable tools in health promotion and training for health professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Game-based approaches to prevention and health promotion: serious games and gamification]. Tolks, D., Lampert, C., Dadaczynski, K., et al.[2021]

Providing numeric information about the likelihood of adverse events (AEs) in medications improves risk comprehension among consumers, as shown in a survey of 905 participants, where those given numeric formats were less likely to overestimate risks.

While numeric formats generally increased willingness to use medications, older adults with lower numeracy skills showed less change in their willingness, suggesting that while numeric information is beneficial, its impact may vary by age and numeracy level.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Numbers matter to informed patient choices: a randomized design across age and numeracy levels. Peters, E., Hart, PS., Tusler, M., et al.[2022]

The game-based learning intervention, Tapamole, achieved a 100% sensitivity in recognizing melanoma features, outperforming the pamphlet group's 95%, indicating its effectiveness in education.

Both the game and pamphlet interventions showed similar specificity and accuracy, but participants found the game more enjoyable, suggesting that engaging educational tools can enhance learning experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online, game-based education for melanoma recognition: A pilot study. Maganty, N., Ilyas, M., Zhang, N., et al.[2019]

A study involving 456 patients with diabetes showed that an online game designed for diabetes self-management education (DSME) led to significant reductions in hemoglobin A1c (HbA1c) levels over 12 months, outperforming a civics game.

Patients with higher baseline HbA1c levels (>75 mmol/mol) experienced even greater improvements, with reductions comparable to starting a new diabetes medication, suggesting that online games can be an effective and scalable method for managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Team-Based Online Game Improves Blood Glucose Control in Veterans With Type 2 Diabetes: A Randomized Controlled Trial. Kerfoot, BP., Gagnon, DR., McMahon, GT., et al.[2022]

Teaching self-management skills through engaging methods, like serious games, is more effective for improving health outcomes in patients with chronic illnesses than just providing information or technical skills.

The eSMART-HD game was specifically designed to enhance interactions between patients with chronic disorders and their healthcare providers, aiming to support learning and promote health-related behavior change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CREATING A SERIOUS GAME FOR HEALTH. Clochesy, JM., Buchner, M., Hickman, RL., et al.[2015]

A scoping review of 22 publications on nutrition education games found that while most studies reported positive outcomes in dietary behavior change and knowledge, the overall quality of research was poor, limiting the ability to conduct a meta-analysis.

The review highlights the need for more rigorous research to better evaluate the effectiveness of these games in promoting healthy dietary behaviors, as current studies show significant diversity in design and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition Education and Dietary Behavior Change Games: A Scoping Review. Baranowski, T., Ryan, C., Hoyos-Cespedes, A., et al.[2023]

The redesigned Schisto and Ladders game significantly increased children's awareness of praziquantel treatment, with 67.9% of participants in the intervention group knowing about it after playing, compared to only 1.1% in the control group.

The game also effectively encouraged treatment compliance, as 65.3% of children in the intervention group sought praziquantel treatment after the trial, demonstrating its potential as a health education tool in schools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Schisto and Ladders version 2: a health educational board game to support compliance with school-based mass drug administration with praziquantel - a pilot study. Ejike, CU., Oluwole, AS., Omitola, OO., et al.[2021]

Many health-related games lack proper validation and research studies often have poor design, making their efficacy uncertain.

The paper suggests guidelines for conducting high-quality studies to better evaluate the effectiveness of games for health, drawing on lessons from digital game-based learning in education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating Efficacy and Validating Games for Health. Kato, PM.[2015]

The analogue game tested in group-based diabetes education significantly enhanced person-centredness and peer dialogues, with 92% of participants and 94% of professionals affirming its effectiveness.

The game fostered a playful atmosphere and active engagement, leading to valuable reflections and insights into the needs of people with diabetes, as reported by both participants and healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing an analogue game to promote peer support and person-centredness in education for people with diabetes: A realist evaluation. Stenov, V., Lindgreen, P., Willaing, I., et al.[2021]

Nondigital board games have a significant positive impact on health-related knowledge, with a large effect size (d* = 0.82) based on a systematic review of 21 studies involving a total of 6554 participants.

The use of board games also shows small-to-moderate effects on health behaviors (d* = 0.33) and biological health indicators (d* = 0.37), suggesting they can be effective tools for improving various health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Board Games for Health: A Systematic Literature Review and Meta-Analysis. Gauthier, A., Kato, PM., Bul, KCM., et al.[2019]

A study involving 31 health professionals revealed significant gaps in knowledge and fear of punishment as major barriers to effectively reporting adverse events in a teaching hospital.

Improving communication and educational practices between leaders and healthcare professionals is essential to enhance the reporting of adverse events, which is crucial for patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The practice of reporting adverse events in a teaching hospital. Siman, AG., Cunha, SGS., Brito, MJM.[2019]

In a study involving 153 employees, 42% participated in testing an app designed for reporting adverse events following immunization (AEFI), with 63% of users rating the experience positively, indicating good acceptance of the app-based technology.

Concerns about data protection were the main reason for declining participation, suggesting that improving data security measures could enhance the acceptability and effectiveness of app-based AEFI reporting systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User preferences for a mobile application to report adverse events following vaccination. Nguyen, MTH., Ott, JJ., Caputo, M., et al.[2020]

In 2001, there were approximately 4.3 million visits to healthcare facilities in the U.S. due to adverse drug events (VADEs), indicating a significant patient safety concern.

The study found that VADEs were more common in elderly patients aged 65-74 and in females, highlighting the need for targeted safety measures in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory care visits for treating adverse drug effects in the United States, 1995-2001. Zhan, C., Arispe, I., Kelley, E., et al.[2019]

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